Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

NCT ID: NCT05740566

Last Updated: 2026-01-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2028-03-26

Brief Summary

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The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Detailed Description

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Conditions

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Small Cell Lung Cancer (SCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tarlatamab

Participants will receive tarlatamab as an intravenous (IV) infusion.

Group Type EXPERIMENTAL

Tarlatamab

Intervention Type DRUG

Tarlatamab will be administered as an IV infusion.

Standard of Care

Participants will receive treatment per local standard of care (SOC).

Group Type ACTIVE_COMPARATOR

Lurbinectedin

Intervention Type DRUG

Lurbinectedin will be administered per local SOC.

Topotecan

Intervention Type DRUG

Topotecan will be administered per local SOC.

Amrubicin

Intervention Type DRUG

Amrubicin will be administered per local SOC.

Interventions

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Tarlatamab

Tarlatamab will be administered as an IV infusion.

Intervention Type DRUG

Lurbinectedin

Lurbinectedin will be administered per local SOC.

Intervention Type DRUG

Topotecan

Topotecan will be administered per local SOC.

Intervention Type DRUG

Amrubicin

Amrubicin will be administered per local SOC.

Intervention Type DRUG

Other Intervention Names

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AMG 757

Eligibility Criteria

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Inclusion Criteria

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
* Participants who progressed or recurred following 1 platinum-based regimen.
* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
* Minimum life expectancy of 12 weeks.
* Adequate organ function.

Exclusion Criteria

* Disease Related

* Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
* Diagnosis or evidence of leptomeningeal disease.
* Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
* Other Medical Conditions

* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
* History of solid organ transplantation.
* History of other malignancy within the past 2 years, with exceptions defined in the protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months prior to first dose of study treatment.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
* Presence or history of viral infection based on criteria per protocol.
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
* Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Prior/Concomitant Therapy

* Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
* Prior therapy with any selective inhibitor of the DLL3 pathway.
* Participant received more than one prior systemic therapy regimen for SCLC.
* Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
* Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
* Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
* Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
* Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
* Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
* Major surgical procedures within 28 days prior to first dose of study treatment.
* Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
* Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Diagnostic Assessments

* Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, with exceptions defined in the protocol.
* Other Exclusions

* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
* Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
* Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
* Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
* Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
* History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation..
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

University of California Los Angeles

Santa Monica, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Illinois Chicago

Chicago, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Pikeville Medical Center

Pikeville, Kentucky, United States

Site Status

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Site Status

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

Site Status

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Site Status

University of Missouri Health Care

Columbia, Missouri, United States

Site Status

Summit Medical Group, Overlook Oncology Center

Summit, New Jersey, United States

Site Status

New York University Grossman School of Medicine and New York University Langone Hospitals

New York, New York, United States

Site Status

Perlmutter Cancer Center at New York University Langone Hospital----Long Island

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Northport Veterans Affairs Medical Center

Northport, New York, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

Site Status

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States

Site Status

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Swedish Cancer Institute Medical Oncology

Edmonds, Washington, United States

Site Status

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status

Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province, Argentina

Site Status

Clinica Viedma

Viedma, Río Negro Province, Argentina

Site Status

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

Site Status

Instituto Argentino de Diagnostico y Tratamiento IADT

Buenos Aires, , Argentina

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Sanatorio Allende

Córdoba, , Argentina

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Liverpool Hospital

Liverpool, New South Wales, Australia

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Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

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Monash Medical Centre

Clayton, Victoria, Australia

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The Alfred Hospital

Melbourne, Victoria, Australia

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Medizinische Universitaet Graz

Graz, , Austria

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Universitaetsklinikum Krems

Krems, , Austria

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

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Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , Belgium

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AZ Delta Campus Rumbeke

Roeselare, , Belgium

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Vitaz campus Sint-Niklaas Moerland

Sint-Niklaas, , Belgium

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Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

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Instituto de Ensino e Pesquisa do Hospital da Bahia

Salvador, Estado de Bahia, Brazil

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Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

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Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

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Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital de Amor da Amazonia

Porto Velho, Rondônia, Brazil

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Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

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Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil

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Oncologia Rede D Or

São Paulo, São Paulo, Brazil

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Instituto Coi

Rio de Janeiro, , Brazil

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Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

São Paulo, , Brazil

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London Health Sciences Centre

London, Ontario, Canada

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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Anhui Chest Hospital

Hefei, Anhui, China

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Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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The Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, China

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Army Special Medical Center of Peoples Liberation Army

Chongqing, Chongqing Municipality, China

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

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Jiangmen Central Hospital

Jiangmen, Guangdong, China

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The 4th Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

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Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

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Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

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Hunan Cancer Hospital

Changsha, Hunan, China

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Subei Peoples Hospital

Yangzhou, Jiangsu, China

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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Jilin Cancer Hospital

Changchun, Jilin, China

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Jinan Central Hospital

Jinan, Shandong, China

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Shandong Tumor Hospital

Jinan, Shandong, China

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Linyi Cancer Hospital

Linyi, Shandong, China

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

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The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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Beijing Chest Hospital, Capital Medical University

Beijing, , China

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Fujian Cancer Hospital

Fuzhou, , China

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Tianjin Peoples Hospital

Tianjin, , China

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Weihai Municipal Hospital

Weihai, , China

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Fakultni nemocnice Brno

Brno, , Czechia

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Masarykuv onkologicky ustav

Brno, , Czechia

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Fakultni nemocnice Olomouc

Olomouc, , Czechia

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Nemocnice Agel Ostrava-Vitkovice as

Ostrava-Vitkovice, , Czechia

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Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

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Rigshospitalet

Copenhagen, , Denmark

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Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, , France

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Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

Lille, , France

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Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

Limoges, , France

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Centre Leon Berard

Lyon, , France

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Centre Hospitalier Universitaire Nord

Marseille, , France

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Institut Curie

Paris, , France

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, , France

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Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Strasbourg, , France

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Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, , France

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Gustave Roussy

Villejuif, , France

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Charite Universitaetsmedizin Berlin, Campus Virchow

Berlin, , Germany

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Universitaetsklinikum Koeln

Cologne, , Germany

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Universitaetsklinikum Dresden

Dresden, , Germany

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Universitaetsklinikum Essen

Essen, , Germany

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Asklepios Fachkliniken Muenchen Gauting

Gauting, , Germany

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LungenClinic Grosshansdorf GmbH

Großhansdorf, , Germany

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Robert-Bosch-Krankenhaus

Stuttgart, , Germany

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Universitaetsklinikum Wuerzburg

Würzburg, , Germany

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Saint Savas Hospital

Athens, , Greece

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Henry Dunant Hospital Center

Athens, , Greece

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Thoracic General Hospital Of Athens Sotiria

Athens, , Greece

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Alexandra Hospital

Athens, , Greece

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University Hospital of Heraklion

Heraklion - Crete, , Greece

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Olympion Therapeftirio General Clinic Of Patras

Pátrai, , Greece

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Saint Luke Hospital

Thessaloniki, , Greece

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European Interbalkan Medical Center

Thessaloniki, , Greece

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Semmelweis Egyetem

Budapest, , Hungary

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Orszagos Koranyi Pulmonologiai Intezet

Budapest, , Hungary

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Matrai Gyogyintezet

Gyöngyös, , Hungary

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Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

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Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, , Hungary

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Reformatus Pulmonologiai Centrum

Törökbálint, , Hungary

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Beaumont Hospital

Dublin, , Ireland

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Rambam Medical Center

Haifa, , Israel

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Hadassah Ein-Kerem Medical Center

Jerusalem, , Israel

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Meir Medical Center

Kfar Saba, , Israel

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Rabin Medical Center

Petah Tikva, , Israel

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Humanitas Gavazzeni

Bergamo, , Italy

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Azienda Ospedaliera Universitaria Renato Dulbecco

Catanzaro, , Italy

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Ospedale Policlinico San Martino IRCCS

Genova, , Italy

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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), , Italy

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Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, , Italy

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Azienda Ospedaliera San Giovanni Addolorata

Roma, , Italy

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National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

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Aichi Cancer Center

Nagoya, Aichi-ken, Japan

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National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

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National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

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Kurume University Hospital

Kurume-shi, Fukuoka, Japan

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National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

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Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

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Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

Sendai Kousei Hospital

Sendai, Miyagi, Japan

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Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status

Okayama University Hospital

Okayama, Okayama-ken, Japan

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Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

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Osaka International Cancer Institute

Osaka, Osaka, Japan

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Kindai University Hospital

Osakasayama-shi, Osaka, Japan

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Saitama Medical University International Medical Center

Hidaka-Shi, Saitama, Japan

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Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

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Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

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National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

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The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

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Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

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University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

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Hospital Tengku Ampuan Afzan

Kuantan, Pahang, Malaysia

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Sarawak General Hospital

Kuching, Sarawak, Malaysia

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coi Centro Oncologico Internacional sapi de cv

Tlajomulco de Zúñiga, Jalisco, Mexico

Site Status

Health Pharma Professional Research SA de CV

Mexico City, Mexico City, Mexico

Site Status

Oncare

Mexico City, Mexico City, Mexico

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Universitair Medisch Centrum Groningen

Groningen, , Netherlands

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Leids Universitair Medisch Centrum

Leiden, , Netherlands

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Erasmus Medisch Centrum

Rotterdam, , Netherlands

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Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

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Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, , Poland

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Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

Krakow, , Poland

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Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

Poznan, , Poland

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Hospital da Luz, SA

Lisbon, , Portugal

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Hospital Cuf Descobertas

Lisbon, , Portugal

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Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

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Hospital Cuf porto

Porto, , Portugal

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Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, , Romania

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Centrul de Oncologie Sf Nectarie SRL

Craiova, , Romania

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Institutul Regional de Oncologie Iasi

Iași, , Romania

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SC Oncomed SRL

Timișoara, , Romania

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National Cancer Centre Singapore

Singapore, , Singapore

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Tan Tock Seng Hospital

Singapore, , Singapore

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Chungbuk National University Hospital

Cheongju Chungbuk, , South Korea

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National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

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Gachon University Gil Hospital

Incheon, , South Korea

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Gyeongsang National University Hospital

Jinju, , South Korea

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

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Severance Hospital Yonsei University Health System

Seoul, , South Korea

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Asan Medical Center

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

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Ulsan University Hospital

Ulsan, , South Korea

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Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

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Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

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Hospital del Mar

Barcelona, Catalonia, Spain

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Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

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Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

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Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

A Coruña, Galicia, Spain

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Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

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Fundacion Jimenez Diaz

Madrid, , Spain

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Hospital Clinico San Carlos

Madrid, , Spain

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Hospital Universitario 12 de Octubre

Madrid, , Spain

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Kantonsspital Graubuenden

Chur, , Switzerland

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Freiburg Spital

Fribourg, , Switzerland

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Hopitaux universitaires de Geneve

Geneva, , Switzerland

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Kantonsspital Sankt Gallen

Sankt Gallen, , Switzerland

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Kantonsspital Winterthur

Winterthur, , Switzerland

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

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Veterans General Hospital - Taichung

Taichung, , Taiwan

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National Cheng Kung University Hospital

Tainan, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Ankara Bilkent Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, , Turkey (Türkiye)

Site Status

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, , Turkey (Türkiye)

Site Status

University College London Hospital

London, , United Kingdom

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Guys Hospital

London, , United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada China Czechia Denmark France Germany Greece Hungary Ireland Israel Italy Japan Malaysia Mexico Netherlands Poland Portugal Romania Singapore South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gumus M, Lugini A, Zhu B, Yu Y, Korantzis I, Han JY, Ciuleanu TE, Ahn MJ, Rocha P, Mazieres J, Lau SCM, Schuler M, Blackhall F, Yoshida T, Owonikoko TK, Paz-Ares L, Jiang T, Hamidi A, Gauto D, Recondo G, Rudin CM; DeLLphi-304 Investigators. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jul 24;393(4):349-361. doi: 10.1056/NEJMoa2502099. Epub 2025 Jun 2.

Reference Type BACKGROUND
PMID: 40454646 (View on PubMed)

Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.

Reference Type DERIVED
PMID: 39530627 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

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Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20210004

Identifier Type: -

Identifier Source: org_study_id

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